18f-fluoroazomycin arabinoside pet-ct in diagnosing solid tumors in patients

Conditions: Malignant Breast Neoplasm; Malignant Colorectal Neoplasm; Malignant Pancreatic Neoplasm; Malignant Solid Neoplasm

Summary: this early phase i trial studies how well 18f-fluoroazomycin arabinoside positron emission tomography (pet)-computed tomography (ct) works in diagnosing solid tumors. using 18f-fluoroazomycin arabinoside with pet-ct may help doctors plan better treatment for patients with solid tumors. 18f-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a pet-ct scan.

primary objectives: i. to evaluate the feasibility of pet-ct using 18f-fluoroazomycin arabinoside (\[18f\]faza) and to determine the optimal imaging time to detect hypoxia in solid tumors. secondary objectives: i. to determine the variability of imaging findings from repeated \[18f\]faza pet-ct studies over \>= 24 hours up to 10 days. ii. to confirm the safety of \[18f\]faza administered during pet-ct imaging of hypoxia of solid tumors. outline: patients are assigned to 1 of 2 groups. group a: patients receive 18f-fluoroazomycin arabinoside intravenously (iv) and after 60 minutes undergo 5 pet-ct scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2. group b: patients receive 18f-fluoroazomycin arabinoside iv and after 60 minutes undergo 5 or less pet-ct scans on day 1 and 5 or less pet-ct scans \>= 24 hours later up to 10 days. after completion of study treatment, patients are followed up at 24 hours and at 30 days.

Eligibility criteria:
inclusion criteria: * patients with histopathologic diagnosis of a solid tumor. all solid tumors will be considered, but patients with breast, pancreas, and colorectal masses will be prioritized. * patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by ct, magnetic resonance imaging \[mri\], ultrasonography or mammography) to allow reliable pet imaging. * a patient who has not received systemic or loco-regional treatment of the tumor within the last month. * ability of the subject, or the legally authorized representative (lar) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent. * patients who are not expected to receive cancer therapy before imaging sessions are completed. exclusion criteria: * pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18f\] faza in pregnancy are not known. a urine or serum pregnancy test will be performed before accrual after informed consent is obtained. * lactation should be suspended for at least two days following the administration of \[18f\] faza to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman. * subjects with contraindications to the use of \[18f\] faza including confirmed allergy. * patients with a body weight of 400 pounds or more, or a body mass index (bmi) which precludes their entry into the bore of the pet/ct scanner, because the findings will probably be compromised in image quality with ct, pet/ct and mri. * any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.